Hemostasis and flushing method and apparatus for trans-catheter annuloplasty

Abstract

A flushing and hemostasis apparatus for a trans-catheter surgical procedure may be provided with an elongated body. A seal assembly may be located at a proximal end of the elongated body and configured to receive a distal end of an implant loading tool therethrough. A valve assembly may be located at a distal end of the elongated body and may include a flush port. In some embodiments, the valve assembly is configured to move between an open position in which the flush port is in fluid communication with the mid-section of the elongated body and a closed position in which the distal end of the elongated body is sealed off from the mid-section. A mid-section of the elongated body may be configured to receive an element protruding from the distal end of the implant loading tool. Other flushing and hemostasis tools and methods of use are also provided.

What is claimed is: 
     
         1 . A flushing and hemostasis apparatus for a trans-catheter surgical procedure, the apparatus comprising:
 an elongated body having a proximal end, a distal end, and a mid-section located between the proximal end and the distal end;   a seal assembly located at the proximal end of the elongated body and configured to receive a distal end of an implant loading tool therethrough; and   a valve assembly located at the distal end of the elongated body and comprising a flush port, the valve assembly configured to move between an open position in which the flush port is in fluid communication with the mid-section of the elongated body and a closed position in which the distal end of the elongated body is sealed off from the mid-section,   wherein the mid-section is configured to receive an element protruding from the distal end of the implant loading tool.   
     
     
         2 . The apparatus of  claim 1 , wherein at least a portion of the mid-section of the elongated body is transparent. 
     
     
         3 . The apparatus of  claim 1 , wherein the mid-section is configured to receive a tether puller protruding from the distal end of the implant loading tool. 
     
     
         4 . The apparatus of  claim 1 , wherein the seal assembly comprises a rotatable collar that is configured to alternately tighten and loosen a seal around the distal end of the implant loading tool. 
     
     
         5 . The apparatus of  claim 1 , wherein the valve assembly is configured to allow air and fluid from the implant loading tool to flow out of the flush port. 
     
     
         6 . The apparatus of  claim 1 , wherein the valve assembly is configured to be attached to a vacuum source to allow air and fluid to be drawn out of the implant loading tool. 
     
     
         7 . The apparatus of  claim 1 , wherein the valve assembly is configured to be attached to a fluid source to allow fluid to be introduced into the implant loading tool. 
     
     
         8 . An outer guide configured for a trans-catheter surgical procedure, the outer guide comprising:
 a proximal handle having a proximal end, a distal end, and a mid-section located between the proximal end and the distal end, wherein the proximal end and mid-section are configured to receive a distal end of an implant loading tool therein;   a flushing chamber located within the proximal handle;   a closed distal valve located within the proximal handle distal to the flushing chamber, the distal valve configured to seal against the distal end of the implant loading tool when received therethrough and configured to remain closed when the implant loading tool is not received therethrough;   an open proximal valve located within the proximal handle proximal to the flushing chamber, the proximal valve configured to seal against the distal end of the implant loading tool when received therethrough and configured to remain open when the implant loading tool is not received therethrough; and   a flushing port located on the proximal handle and in fluid communication with the flushing chamber, thereby allowing fluid to be constantly flushed into the flushing chamber through the flushing port and flow out of the open proximal valve when the implant loading tool is being introduced into the proximal handle to create a bolus of fluid beyond the proximal end of the proximal handle to allow the distal tip of the implant loading tool to make contact with the bolus of fluid before entering the proximal open valve, inhibiting air from being trapped in the outer guide or the implant loading tool.   
     
     
         9 . The outer guide of  claim 8 , wherein the closed distal valve is a single slit valve. 
     
     
         10 . The outer guide of  claim 8 , wherein the open proximal valve is an hourglass-shaped valve. 
     
     
         11 . The outer guide of  claim 8 , further comprising a second flushing port located on the proximal handle and in fluid communication with a central bore of the proximal handle at location that is distal to the closed distal valve. 
     
     
         12 . The outer guide of  claim 8 , wherein the open proximal valve comprises a rotatable housing that permits the proximal valve to be tightly compressed, including over any tethers passing through it, thereby providing a redundant and more secure seal than the closed proximal valve. 
     
     
         13 . A flushing and hemostasis system comprising:
 the outer guide of  claim 8 ; and   an implant loading tool configured to receive a surgical implant in a central bore of the implant loading tool and to allow the implant to be pushed out of a distal end of the loading tool and into the outer guide by a steerable inner catheter, thereby allowing the steerable inner catheter to push the implant through the entire length of the outer guide and manipulate the implant inside a patient without the implant or the steerable inner catheter coming into contact with any hemostasis valves in the outer guide.   
     
     
         14 . A bifurcated hemostasis tool comprising:
 a housing having a proximal end and a distal end;   a single tube extending from the distal end of the housing;   at least two bores located through the proximal end of the housing, each of the bores converging together and being in fluid communication with the single tube;   a single hemostasis valve located in each of the bores.   
     
     
         15 . The tool of  claim 14 , wherein each of the valves is a single slit valve. 
     
     
         16 . The tool of  claim 15 , wherein each of the valves comprises an interior portion, a proximal exterior layer and a distal exterior layer, wherein the proximal exterior layer and the distal exterior layer are each thinner than the interior portion and each comprise a material having a higher durometer than that of a material of the interior portion. 
     
     
         17 . The tool of  claim 16 , wherein the proximal exterior layer and the distal exterior layer of each of the valves comprises a pair of beveled surfaces aligned with a slit of the interior portion. 
     
     
         18 . The tool of  claim 17 , wherein the interior portion, the proximal exterior layer and the distal exterior layer of each of the valves is formed of silicone. 
     
     
         19 . The tool of  claim 18 , wherein each of the valves has a coating that comprises Parylene. 
     
     
         20 . The tool of  claim 15 , wherein each of the valves is provided with a rotating compression cylinder, wherein each compression cylinder is movable between a first position in which one of the valves is compressed so that it is stiffer and a second position in which the valve is uncompressed or less compressed and is less stiff. 
     
     
         21 . The tool of  claim 20 , wherein each of the compression cylinders comprises a radially extending knob configured to rotate an associated compression cylinder. 
     
     
         22 . The tool of  claim 20 , wherein each of the compression cylinders may be operated individually. 
     
     
         23 . The tool of  claim 20 , wherein each of the compression cylinders may be infinitely variable between the first position and the second position. 
     
     
         24 . The tool of  claim 14  further comprising a flush port located on the housing. 
     
     
         25 . A method of flushing a surgical instrument system and achieving hemostasis, the method comprising;
 providing an outer guide, an inner steerable catheter, an implant loading tool slidably coupled to the inner steerable catheter, and a flushing tool, the outer guide comprising a closed distal valve, an open proximal valve and flushing chamber located therebetween;   placing the flushing tool over a distal end of the implant loading tool;   filling the inner steerable catheter, the implant loading tool and the flushing tool with a sterile fluid;   closing a valve located at a distal end of the flushing tool;   introducing a sterile fluid into the flushing chamber so that it flows out of the open proximal valve to create a bolus of fluid beyond a proximal end of the outer guide;   removing the flushing tool from the distal end of implant loading tool; and   introducing the distal tip of the implant loading tool to the bolus of fluid before introducing it through the proximal open valve, thereby inhibiting air from being trapped in the outer guide or the implant loading tool during insertion of the implant loading tool into the outer guide.   
     
     
         26 . The method of  claim 25 , further comprising introducing the distal tip of the implant loading tool through the closed distal valve. 
     
     
         27 . The method of  claim 26 , further comprising using the inner steerable catheter to push a surgical implant out of the implant loading tool and through the outer guide until the implant emerges from a distal end of the outer guide and into a patient. 
     
     
         28 . The method of  claim 27 , further comprising manipulating the implant within the patient with the inner steerable catheter without the inner steerable catheter contacting the closed distal valve or the open proximal valve. 
     
     
         29 . The method of  claim 25 , further comprising providing a series of vent holes along at least one bore of a proximal handle of the inner steerable catheter. 
     
     
         30 . The method of  claim 25 , further comprising:
 removing the inner steerable catheter and the implant loader from the outer guide; and   introducing a distal end of a bifurcated hemostasis tool through the open proximal valve and the closed distal valve.   
     
     
         31 . The method of  claim 30 , further comprising, between the steps of removing the inner steerable catheter and introducing the distal end of the bifurcated hemostasis tool:
 introducing a sterile fluid into the flushing chamber of the outer guide so that it flows out of the open proximal valve to create a bolus of fluid beyond a proximal end of the outer guide; and   introducing the distal end of the bifurcated hemostasis tool to the bolus of fluid before introducing it through the proximal open valve, thereby inhibiting air from being trapped in the outer guide or the bifurcated hemostasis tool during insertion of the bifurcated hemostasis tool into the outer guide.   
     
     
         32 . The method of  claim 31 , further comprising, before introducing the distal end of the bifurcated hemostasis tool to the bolus of fluid:
 flushing air out of the bifurcated hemostasis tool and filling it with a sterile fluid.